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Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial.
Hachem, Mariam; Hearn, Tracey; Kelly, Ray; Eer, Audrey; Moore, Belinda; Sommerville, Christine; Atkinson-Briggs, Sharon; Twigg, Stephen; Freund, Meagan; O'Neal, David; Story, David; Brown, Alex; McLean, Anna; Sinha, Ashim; Furler, John; O'Brien, Richard; Tran Duy, An; Clarke, Philip; Braat, Sabine; Koye, Digsu N; Eades, Sandra; Burchill, Luke; Ekinci, Elif.
Affiliation
  • Hachem M; Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Hearn T; Endocrinology, Austin Health, Melbourne, Victoria, Australia.
  • Kelly R; Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Eer A; Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Moore B; Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Sommerville C; Medical Clinic, Rumbalara Aboriginal Cooperative, Mooroopna, Victoria, Australia.
  • Atkinson-Briggs S; Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Twigg S; Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Freund M; Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • O'Neal D; Endocrinology, Austin Health, Melbourne, Victoria, Australia.
  • Story D; Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Brown A; Implementation Science Research Group, University of Melbourne, Melbourne, Victoria, Australia.
  • McLean A; Department of Medicine, Austin Health, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Sinha A; Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Furler J; Medical Clinic, Rumbalara Aboriginal Cooperative, Mooroopna, Victoria, Australia.
  • O'Brien R; Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Tran Duy A; School of Medicine and Public Health, College of Health, Medicine and Wellbeing, Health Behaviour Research Collaborative, University of Newcastle, Newcastle, New South Wales, Australia.
  • Clarke P; Australian Centre for Accelerating Diabetes Innovations (ACADI), Melbourne Medical School, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Braat S; Department of Medicine, FacultyofMedicine,DentistryandHealth Sciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Koye DN; Endocrinology, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.
  • Eades S; Critical Care, FacultyofMedicine,DentistryandHealthSciences, University of Melbourne, Melbourne, Victoria, Australia.
  • Burchill L; Indigenous Genomics, Telethon Kids Institute, Adelaide, South Australia, Australia.
  • Ekinci E; Indigenous Genomics, The Australian National University, Canberra, Australian Capital Territory, Australia.
Trials ; 25(1): 493, 2024 Jul 19.
Article in En | MEDLINE | ID: mdl-39030640
ABSTRACT

BACKGROUND:

Aboriginal and Torres Strait Islander peoples are disproportionately impacted by type 2 diabetes. Continuous glucose monitoring (CGM) technology (such as Abbott Freestyle Libre 2, previously referred to as Flash Glucose Monitoring) offers real-time glucose monitoring that is convenient and easy to use compared to self-monitoring of blood glucose (SMBG). However, this technology's use is neither widespread nor subsidised for Aboriginal and Torres Strait Islander peoples with type 2 diabetes. Building on existing collaborations with a national network of Aboriginal and Torres Strait Islander communities, this randomised controlled trial aims to assess the effect of CGM compared to SMBG on (i) haemoglobin A1c (HbA1c), (ii) achieving blood glucose targets, (iii) reducing hypoglycaemic episodes and (iv) cost-effective healthcare in an Aboriginal and Torres Strait Islander people health setting.

METHODS:

This is a non-masked, parallel-group, two-arm, individually randomised, controlled trial (ACTRN12621000753853). Aboriginal and Torres Strait Islander adults with type 2 diabetes on injectable therapy and HbA1c ≥ 7.5% (n = 350) will be randomised (11) to CGM or SMBG for 6 months. The primary outcome is change in HbA1c level from baseline to 6 months. Secondary outcomes include (i) CGM-derived metrics, (ii) frequency of hypoglycaemic episodes, (iii) health-related quality of life and (iv) incremental cost per quality-adjusted life year gained associated with the CGM compared to SMBG. Clinical trial sites include Aboriginal Community Controlled Organisations, Aboriginal Medical Services, primary care centres and tertiary hospitals across urban, rural, regional and remote Australia.

DISCUSSION:

The trial will assess the effect of CGM compared to SMBG on HbA1c for Aboriginal and Torres Strait Islander people with type 2 diabetes in Australia. This trial could have long-term benefits in improving diabetes management and providing evidence for funding of CGM in this population. TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry ACTRN12621000753853. Registered on 15th June 2021.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Blood Glucose / Glycated Hemoglobin / Blood Glucose Self-Monitoring / Cost-Benefit Analysis / Diabetes Mellitus, Type 2 Limits: Adult / Humans Country/Region as subject: Oceania Language: En Journal: Trials Journal subject: MEDICINA / TERAPEUTICA Year: 2024 Document type: Article Affiliation country:
Fulltext
Add to My VHL
Print
XML
PubMed Links
Search on Google

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Blood Glucose / Glycated Hemoglobin / Blood Glucose Self-Monitoring / Cost-Benefit Analysis / Diabetes Mellitus, Type 2 Limits: Adult / Humans Country/Region as subject: Oceania Language: En Journal: Trials Journal subject: MEDICINA / TERAPEUTICA Year: 2024 Document type: Article Affiliation country: